OBR Daily Commentary

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FDA Speeds Up Examination of 5 Drugs with Priority Review

(BioSpace) Feb 12, 2020 - A number of new medications stand a shot at early regulatory approval thanks to the U.S. Food and Drug Administration (FDA)’s priority review program. This week, the agency handed out a number of such designations, which will hasten potential approval.

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William McGivney, PhD (Posted: February 17, 2020)

quotesEvery once in a while, in my columns, I mention that Rick Pazdur, MD of the FDA NEEDS to be recognized for how he has positively impacted the lives of thousands of patients with Cancer and their Caregivers. Dr. Pazdur has had remarkable success in speeding up FDA approvals for many, many drugs and biologics while at the same time maintaining a process that continues to assure assiduous evaluation of the safety and efficacy of these products. Dr. Pazdur deserves to be awarded the Presidential Medal of Freedom for what he has done in his own quiet way for the people of this country. While Yogi Berra and Chita Rivera were recognized for their contributions with the Presidential Medal, to me, saving and extending the lives of thousands of patients with cancer transcends what may recipients achieved or contributed. Dr. Anthony Fauci is a deserved winner for his tireless efforts to combat the AIDS epidemic and AIDS, the disease. I strongly believe that Dr. Pazdur has worked in the same sphere of achieving good as Dr. Fauci. I have had only had 2 very brief and casual conversations with Dr. Pazdur, so I am not looking to “get something for a close friend”, just for a highly deserving humanitarian. At the opening of the Yogi Berra Museum and Learning Center, Mr Berra said eloquently: “I’m lucky. Usually you’re dead to get your own museum, but I’m still alive to see mine”. It is past time for Dr. Pazdur to receive the recognition and Thanks that he so richly deserves. I have spoken with national cancer provider organizations that agree with my proposal. Let’s work to get this done! quotes

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‘Fail first’ No More: Pennsylvania Moves To Expand Coverage Of Treatments For Advanced Cancers

(The Philadelphia Inquirer) Feb 5, 2020 - Patients in Pennsylvania facing the most serious stage of cancer will no longer be forced to try cheaper drugs before their insurance covers other, more expensive treatments.

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William McGivney, PhD (Posted: February 11, 2020)

quotesThe Pennsylvania legislation described here in the brief article hopefully will serve to do away with an abhorrent practice of payers who put patients and caregivers through an emotional and financial wringer as such payers presume that they can best prescribe for a patient with cancer. That payer-intrusive recommendation often represents a tactical delay that seeks to impose a “fail first” temporal sentence on patients in need who have little extra time to have their treatment directed by that payer. Indeed, this Pennsylvania legislation (and in other states) is a positive but the glass is half-full. As I have often opined: 1. The next version of legislation should cover all recognized off-label uses (e.g., NCCN); 2. Precertification for patients with Cancer should be made illegal. 3. When a payer makes a medical necessity determination, that payer is involved in the practice of Medicine and should be so liable. quotes

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Researchers Develop New Standards For Quality Of Life Measurement In Cancer

(EORTC) Jan 31, 2020 - For the first time, recommendations for the analysis of patient-reported outcomes (PROs) in cancer clinical trials have been developed by an international group of experts. The recommendations will help to determine more consistent and comparable Quality of Life (QoL) results from clinical trials.

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William McGivney, PhD (Posted: February 06, 2020)

quotesAlmost all of us will be patients with a serious illness at some point in our lives. As such, how we feel, how we can function, how we view our survival and mortality, etc. are among the critical components of a quality life. My last sentence demonstrates the overlap of concepts (e.g., QOL and PROs) and sometimes the confusion behind what is being measured on top of the collection of safety and efficacy data. Clearly, the move by EORTC to attempt to “standardize the analysis of PROs in RCTs” will help. Quite frankly, I am not sure what the statement in quotes means exactly, but I do not prioritize the issue highly enough to pull more time away from my other efforts. Notwithstanding that, I do know that in the United States the application of the results of formal PRO assessments, long- and much- talked about, achieve only minor attention in policy-setting and in clinical decision-making. I remember about 5 years ago, being on a public Panel and being asked the first question. With significant timidity, I gave the answer per the above sentence. I thought that the patient advocates, one biopharma rep, and the one government policy person on the Panel would shower me with disdain. Interestingly, I had broken the ice and spoken the truth. My colleagues on the Panel actually responded in general agreement with me. I had made it okay to come out from behind the curtain of political correctness that we see so often on such Panels. PROs are important. But where do they fall in the cascade of issues and wants of the patient? To my mind, patients always see themselves in the upper decile for survival. Patients certainly want to understand the probabilities and degree of pain and discomfort certain Adverse Effects of selected drugs/biologics and other treatments can bestow. As above, the identification of and definition of such outcomes and others (QOL and its component parts) are all relevant. But to date, regulators, payers/MCOs and clinicians in the US generally focus on traditional explanations of risk/benefit in terms of safety and efficacy in their policy setting and decision-making. A 2019 study (Toumi et al, Recent Results Cancer Research) supports this statement. The allotment of valuable and limited resources such as time and money requires the hierarchical prioritization of which outcomes to evaluate in a rigorous, scientific manner. The effort in Europe to achieve more directive, clarifying standardization for PROs is important. It will be interesting to review again in 5-10 years to see where we are with the assessments and application of PROs in decision-making in the US. quotes

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Prostate Cancer
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Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

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Dean Gesme, MD

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Howard S. Hochster, MD

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Howard Sandler, MD, MS, FASTRO

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Michael G. King Jr.

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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

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Ted Okon

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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

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Winston Wong, PharmD

President, W-Squared Group...